An interim final rule placed the narcolepsy medicine oveporexton in Schedule IV of the Controlled Substances Act effective Nov. 12, the Justice Department's Drug Enforcement Administration said.
The action follows the Food and Drug Administration's Aug. 5 approval of Orzeyful, the drug's brand name, to treat narcolepsy type 1 in adults. The Department of Health and Human Services recommended the Schedule IV classification.
The rule appeared in the Federal Register on Nov. 12, with comments due Dec. 14. Its coverage extends to the drug's salts and isomers, forms of a chemical with the same molecular formula but different arrangements, where those forms can exist.
The drug agency issued the measure under the Controlled Substances Act, as amended by the Improving Regulatory Transparency for New Medical Therapies Act.
Separately, the Transportation Department's Federal Aviation Administration proposed requiring replacement of affected main landing gear on Dassault Aviation MYSTERE-FALCON 50, FALCON 2000 and FALCON 2000EX airplanes.
The proposal followed a manufacturing quality problem and a determination that high-temperature oxidation may have affected upper and lower landing-gear torque links during production, the aviation agency said.
Operators would have to replace affected landing gear with serviceable equipment. The proposal would also restrict installation of affected parts under certain conditions. Published Nov. 12, it accepts comments through Dec. 28.
A separate aviation agency proposal would require inspections and changes to flap actuators on Diamond Aircraft Industries DA 50 C airplanes following reports of failures. Those devices move the wing flaps.
The proposed inspections would check whether a black slide grommet had shifted and whether the actuator's rod-end bearing fitted tightly. The proposal would also require modifying the actuator.
After modification, repeated inspections would check for a broken torque seal on the nuts at the bearing attachment, with corrective action where applicable. The proposal would prohibit installing unmodified actuators on any airplane.
The Diamond proposal also appeared Nov. 12, with comments due Dec. 28. Both aircraft measures are proposed rules, rather than requirements already in force.
The aviation agency also published two rules changing instrument approach, takeoff and obstacle departure procedures at certain airports. Both took effect Nov. 12.
The changes respond to revised criteria and changes in airspace operations, including navigational facilities, obstacles and air traffic requirements.
The Postal Service separately proposed changing rules governing companies that advance postage funds to customers. Existing regulations require deposits sufficient to cover those advances.
The proposal addresses circumstances when a company's daily advances exceed its average advance balance deposited with the Postal Service. Published Nov. 12, it accepts comments through Dec. 14.
